COULTER 5C CELL CONTROL— 510(k) K060464

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K060464 for COULTER 5C CELL CONTROL, Substantially Equivalent on 2006-03-28. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 2006-02-22
Decision date: 2006-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.